pharmacy compounding: infection prevention
TRANSCRIPT
Pharmacy Compounding: Infection Prevention
Sam Eberwein, PharmD, MS, BCPSClinical Manager, Sterile Products Area,
Perioperative Services, & Special Formulations
UNC Medical Center Department of PharmacyNovember 8, 2017
What is compounding?
What is compounding?• NC Board of Pharmacy1
» taking two or more ingredients and combining them into a dosage form of a drug, exclusive of compounding by a drug manufacturer, distributor, or packer”
• FDA» “combines, mixes, or alters ingredients of a drug to create a
medication tailored to the needs of an individual patient” 2
» “Compounding does not include mixing, reconstituting, or similar acts that are performed in accordance with the directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling" 3
• USP4
» “The preparation, mixing, assembling, alterating, packaging, and labeling of a drug or drug-delivery device”
• Specifically includes: “Reconstitution or manipulation of commercial products that may require the addition of one or more ingredients.”
1. Pharmacy Practice Act, N.C. Gen. Stat. § 90-85.3.(c)2. FDA FAQ on compounding published 10/06/20153. [21 USC 321 (k) and (m)].4. USP <795> Pharmaceutical Compounding-Nonsterile Preparations
Why do we care? Federal
USP Chapters <1000 enforceable FDA currently using “Enforcement Discretion”
State State Boards of Pharmacy can enforce only if
FD&C Act is within regulations or if they have adopted its own version
The NCBOP has incorporated into its regulations USP 795 and 797 standards (and will include 800)
Why do we care? Scope of applicability
Health care organizations Pharmacies Physician practice facilities Any and all facilities where CSPs are prepared,
stored, and dispensed
The Joint Commission “TJC expects compliance.” “Applies to all personnel who are preparing sterile
products that are going to be used but are going to stored until used”
CSPs Incidents
Beyond Use Dates What is a Beyond Use Date (BUD)?
How does a BUDs compare to: Spike by time Discard after time Expiration date Hang time
USP 795 Risk CategoriesCategories Description ExamplesSimple Compound has a USP
monograph or appears in peer-reviewed literature
Captopril Oral Solution
Moderate Compound that has special calculations or procedures
Morphine sulfate suppositories
Complex Compound that requires special training, environment, facility, equipment, or procedures
Transdermal dosage forms
BUD Assignment – Non-sterileCategories BUDNonaqueous formulations No later than the expiration of the
earliest API or 6 months, whichever is earlier
Water containing oral formulation No later than 14 days when stored at controlled room temp
Water containing Topical/Dermal and Mucosal Liquid and Semisolid Formulation
No later than 30 days
Note: no BUD should never be longer than any ingredient’s expiration.
Stability data that is longer can override these limits, however microbial growth should be considered.
Sterile compounding -Operational issues
Operational
ProcessEnvironment
Equipment
CSP
PreparationTraining Cleaning
Personnel
Literature Accuracy/Sterility - Trissel 20031 and 20052
• Estimated microbial contamination for Low and Medium-risk CSPs
• Evaluated aseptic technique of pharmacists and technicians from 2002-2003 (n=267)- 0.1% contamination for Low-risk CSPs (n=1058)- 5.8% overall contamination rate for Medium-risk
CSPs (n=539)- Even worse rate for staff who regularly
compounded
1. Am J Health Syst Pharm. 2003; 60:1853-552. Am J Health Syst Pharm. 2005; 62:285-288.
2. Put on Hair and Face Covers3. Put on shoe covers
Environmental quality/control
Necessary ISO cleanroom components Airborne particulate count
• PEC (LAFWs/RABS/Barrier isolators): <ISO Class 5• Buffer zone: <ISO Class 7• Anteroom: <ISO Class 8
Air exchanges• >30 exchanges/hour (At least 15 from the PEC)
Positive pressure (non-hazardous) At least 0.02-inch water column
Materials of construction Limit ledges, crevices, etc. Where is the sink?
Environmental quality/control
Single-dose vial Opened or needle punctured single-dose
• >ISO Class 5used within 1 hour• <ISO Class 5used up to 6 hour period*
*(must be continuously exposed)
Storage and Dating
Multiple-dose vial Opened or needle punctured multiple-dose
• 28 days or manufacturer specifications
Storage and Dating
Microbiological BUD Information resources
Chemical stability limits from literature or testing USP Chapter <797>
It is your professional obligation to determine the “risk level”
Putting it all together
Case studies• Your hospital has just purchased an ENT clinic and has
asked your advice on reducing drug costs for the clinic. At nearly $1000 a vial, the Botox they are using to treat torticollis represents more than half their drug expenditure.
• Unfortunately, the average dose is only 0.1 mL of the 1 mL vial, leaving most of each vial wasted. In a dramatic cost savings move, a physician who is new to the clinic has started drawing up doses for all of his patients for the day from a single vial. This innovative practice is anticipated to save hundreds of thousands of dollars a year for the clinic.
• What would you advise the new clinic leadership to do?
Case studies• At a clinic visit, a nurse expresses concern that a patient’s
family is violating USP 797 and asks you to speak with the mother.
• When asked, the mother describes how she draws up two doses at a time from her son’s vial of filgrastim. One dose she gives immediately and the other she stores in the refrigerator for the next day.
• You know that filgrastim vials are single dose vials and you also know that they are quite expensive and this patient has poor insurance coverage.
• How do you respond to the nurse’s concerns and what do you advise the mother?
Video Tour of Pharmacy
Pharmacy Compounding: Infection Prevention
Sam Eberwein, PharmD, MS, BCPSClinical Manager, Sterile Products Area,
Perioperative Services, & Special Formulations
UNC Medical Center Department of PharmacyNovember 8, 2017